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Multi-kinase inhibitor

sorafenib tosylate for Liver Cancer

Phase 2
Waitlist Available
Led By Ronald Busuttil
Research Sponsored by Jonsson Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed up to 2 years
Awards & highlights

Study Summary

This study is evaluating whether sorafenib is safe and effective in preventing liver cancer recurrence in high risk patients following liver transplantation.

Eligible Conditions
  • Liver Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Recurrence-free survival, evaluated using the new international criteria proposed by the Modified Response Evaluation Criteria in Solid Tumors (mRECIST) Committee
Secondary outcome measures
Adverse events assessed in terms of seriousness, severity, and relationship to the study material according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Impact of biomarkers (AFP and PIVKA II)
Impact of drug-drug interactions
+4 more

Side effects data

From 2014 Phase 2 trial • 20 Patients • NCT01502410
20%
Pain
10%
Lipase increased
10%
Hypoalbuminemia
10%
Respiratory, thoracic and mediastinal disorders - Other
10%
Anorexia
10%
Pericardial effusion
10%
Atelectasis
10%
Blood bilirubin increased
10%
Neutrophil count decreased
10%
Musculoskeletal and connective tissue disorder - Other
10%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other
10%
Pleural effusion
10%
Rash maculo-papular
10%
Alkaline phosphatase increased
10%
Hypocalcemia
10%
Hypophosphatemia
10%
Back pain
10%
Diarrhea
10%
Neck pain
10%
Lung infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Group 1 Relapsed/Refractory Rhabdomyosarcoma
Group 2 Relapsed/Refractory Wilms Tumor

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm I (sorafenib tosylate)Experimental Treatment2 Interventions
Patients receive sorafenib tosylate PO BID.
Group II: Arm II (placebo)Placebo Group2 Interventions
Patients receive placebo PO BID.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
sorafenib tosylate
2005
Completed Phase 2
~920

Find a Location

Who is running the clinical trial?

Jonsson Comprehensive Cancer CenterLead Sponsor
359 Previous Clinical Trials
26,062 Total Patients Enrolled
5 Trials studying Liver Cancer
69 Patients Enrolled for Liver Cancer
BayerIndustry Sponsor
2,235 Previous Clinical Trials
25,325,543 Total Patients Enrolled
Ronald BusuttilPrincipal InvestigatorJonsson Comprehensive Cancer Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Sorafenib Tosylate Following a Liver Transplant in Treating Patients With Liver Cancer
2012. "Sorafenib Tosylate Following a Liver Transplant in Treating Patients With Liver Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01624285.
~2 spots leftby Apr 2025
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